MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW PEDICLE SCREW 7X50; SPINE PEDICLE SCREW

Model Number	03.50.032
Medical Device Problem Codes	Fracture (1260); Migration (4003)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	04/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director: 10 months after primary stabilization at l5-s1, pseudoarthrosis develops and the surgeon decides to proceed with reoperation.At surgery, two of the 4 screws are found loose and one broken.The quality of the images supplied is very poor and assessment of the position of the screws as well as detection of developmental instability at adjacent levels can hardly be detected.Probably after few months the l4-l5 relative position was also pathologically modified.The primary surgeon had left straight short rods and no lordosis was imposed at l5-s1, but we cannot determine the effect that this choice may have had on the final result.One screw was found broken most probably because fusion was not attained after 10 months - it should be noted that the patient is reportedly overweight.When fusion is not achieved, it is possible that the temporary implants cannot sustain fatigue stresses and fail.In this case, loosening of two more screws made device fracture more likely.Also, subsidence of the interbody cage can be seen, and this is an additional factor that may contribute to enhance stresses on the pedicle screws and inhibit fusion.The root cause that led to pseudoarthrosis and failure of fusion cannot be determined with the information at hand.Preliminary investigation performed by r&d project manager: according to the picture of the explanted device, the pedicle screw broke under the head.The failure of the broke screw is compatible with the potential root cause indicated in the clinical evaluation.No picture of the other devices involved in the complaint are available, so no analysis is possible on them.The event involves 4 screws: pedicle screw 03.50.032 pedicle screw 7x50 lot.Unknown.
Event or Problem Description
Revision surgery due to pseudoarthrosis l5/s1.All 4 screws were taken out.2 were loose (s1 and l5 screws), 1 was broken (s1 left).At about 10 months form primary the screws were replaced with 8x 50mm fenestrated screws, but no cement augmentation has been made.

• Brand Name: PEDICLE SCREW PEDICLE SCREW 7X50
• Common Device Name: SPINE PEDICLE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16884699
• Report Number: 3005180920-2023-00335
• Device Sequence Number: 6141883
• Product Code: KWP
• UDI-Device Identifier: 07630030834301
• UDI-Public: 07630030834301
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K121115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.50.032
• Device Catalogue Number: 03.50.032
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 05/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White